Trials Sponsors Conditions Drugs Pricing

Conditions

Recurrent Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

Overall Response Rate (Complete and Partial Responses) as Defined by the International Workshop Criteria
Complete Response (CR) - Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms. Partial Response (PR) requires a \>=50% decrease in sum of the products of the greatest dimension (SPD) of the six largest dominant nodes or nodal masses. Overall Response Rate (ORR) - The number of patients who achieve a CR or PR divided by the total number of evaluable patients. We report the Overall Response Rate here.
Up to 12, 28-day cycles.

Secondary Outcomes (4)

Time to Progression
Patients were followed up to five years after registration.
Duration of Response
Response duration is followed up to 5 years from registration.
Toxicity
Assessed during treatment (up to 12, 28-day cycles)
Overall Survival
Patients were followed for survival status for up to 5 years.

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.

Biological: rituximabDrug: temsirolimus

Interventions

rituximabBiological

375 mg/m\^2 Given IV

Also known as: IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8, Rituxan

Arm I

temsirolimusDrug

25 mg given IV

Also known as: CCI-779, cell cycle inhibitor 779, Torisel

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histologically confirmed\* mantle cell lymphoma (MCL)
Relapsed, refractory, or stable disease after prior treatment

Sponsors & Collaborators

National Cancer Institute (NCI)
NIHlead

Study Sites (195)

Mobile Infirmary Medical Center

Mobile, Alabama, 36607, United States

The Medical Center of Aurora

Aurora, Colorado, 80012, United States

Boulder Community Hospital

Boulder, Colorado, 80301, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, 80907, United States

Saint Anthony Central Hospital

Denver, Colorado, 80204, United States

Porter Adventist Hospital

Denver, Colorado, 80210, United States

Exempla Saint Joseph Hospital

Denver, Colorado, 80218, United States

Related Publications (1)

Ansell SM, Tang H, Kurtin PJ, Koenig PA, Inwards DJ, Shah K, Ziesmer SC, Feldman AL, Rao R, Gupta M, Erlichman C, Witzig TE. Temsirolimus and rituximab in patients with relapsed or refractory mantle cell lymphoma: a phase 2 study. Lancet Oncol. 2011 Apr;12(4):361-8. doi: 10.1016/S1470-2045(11)70062-6.
PMID: 21440503DERIVED

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

RituximabtemsirolimusSirolimus

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Results Point of Contact

Title: Stephen M. Ansell, M.D., Ph.D.
Organization: Mayo Clinic

Study Officials

Stephen Ansell
North Central Cancer Treatment Group
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: LTE60
Restrictive Agreement: Yes

Enrollment

71 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: NIH
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 3, 2005

First Posted

May 4, 2005

Study Start

May 2005

Date type not reported

This date has not been verified as actual or estimated.

CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Arm I

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (195)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Arm I

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (195)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Locations